Vicks Sinex Severe Capsule, Liquid Filled
FDA Label NDC 37000-951

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Vicks Sinex Severe (NDC 37000-951). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients (in each liquicap), purpose, uses, liver warning, allergy alert:, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredients (in Each Liquicap)

→ Purpose

→ Uses

→ Liver Warning

→ Allergy Alert:

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ Otc - When Using

→ Stop Use And Ask A Doctor If

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Overdose Warning

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel - 24 Liquicap Carton

Other

Drug Facts

Made in Canada

DIST. BYPROCTER & GAMBLE,
CINCINNATI OH 45202

Active Ingredients (In Each Liquicap)

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Expectorant

Nasal decongestant

Uses

temporarily relieves symptoms due to the common cold (or a cold)

minor aches and pains
headache
fever
nasal congestion
sinus congestion & pressure
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
temporarily relieves symptoms due to hay fever or other upper respiratory allergies
minor aches and pains
headache
nasal congestion
sinus congestion & pressure

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take

more than 8 LiquiCaps in 24 hours, which is the maximum daily amount for this product
with other drugs containing acetaminophen
3 or more alcoholic drinks daily while using this product

Allergy Alert:

acetaminophen may cause severe skin reactions. Symptoms may include:

Skin reddening
Blisters
Rash

If a skin reaction occurs, stop use and seek medical help right away

Do Not Use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to enlarged prostate gland
cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

Otc - When Using

When using this product, do not use more than directed

Stop Use And Ask A Doctor If

you get nervous, dizzy or sleepless
pain, nasal congestion, or cough gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

take only as directed
do not exceed 8 LiquiCaps per 24 hrs

adults & children 12 yrs & over 2 LiquiCaps with water every 4 hrs

children 4 to under 12 yrs ask a doctor

children under 4 yrs do not use

Other Information

do not exceed 25°C

Inactive Ingredients

ammonium hydroxide, D&C Red No. 33, FD&C Red No.40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, simethicone, sorbitol sorbitan solution, titanium dioxide